MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3541258
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: breast prosthesis rupture.Explantation month, day, and year: (b)(6) 2022.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a primary breast augmentation procedure with a mentor memoryshape breast implant 315cc gel breast prosthesis that ruptured post implantation.Rupture of the patient¿s left breast prosthesis was diagnosed via mri.As a result, the patient is scheduled to undergo explantation on (b)(6) 2022.
Additional Manufacturer Narrative
On 23-sep-2022, the mentor failure analysis lab received the device for evaluation.On 28-sep-2022, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, a rupture occurred in the breast implant.The product was returned to mentor for evaluation.Mentor conducted a visual inspection.Visual analysis of the returned sample revealed that the breast implant was found to be ruptured.As the authorization form for examination was not received, the product evaluation lab couldn¿t identify a conclusion due to the specific nature of this rupture.The evaluation was limited to non-destructive testing.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: rupture can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.The following things may cause the implant to rupture: damage by surgical instruments; stressing the implant during implantation and weakening it; folding or wrinkling of the implant shell; excessive force to the chest (e.G.During closed capsulotomy); trauma; compression during mammographic imaging; and severe capsular contracture.Breast implants may also simply wear out over time.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 05-oct-2022, mentor received additional information about the event.The patient had only her left breast prosthesis explanted and it was replaced with a mentor memoryshape breast implant 315cc gel breast prosthesis.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 16-jun-2023, mentor re-evaluated the suspect medical device.Device evaluation summary: according to the information received, a rupture occurred in the breast implant.The product was returned to mentor for evaluation.Mentor then conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the breast implant was found to be ruptured.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in an area of the tear on the anterior aspect, measuring approximately 0.3 cm.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.The cause of the rupture in the remaining area of the tear could not be identified.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Capa activity was not required.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 14902255
• Report Number: 1645337-2022-07770
• Device Sequence Number: 5089788
• Product Code: FTR
• UDI-Device Identifier: 00081317005469
• UDI-Public: 00081317005469
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 3541258
• Device Catalogue Number: 3541258
• Device Lot Number: 6752628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 09/23/2022; 10/05/2022; 06/16/2023
• Initial Report FDA Received Date: 07/03/2022
• Supplement Report FDA Received Date: 09/30/2022; 10/21/2022; 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female